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Team Lead - CMC Systems Oversight

Lexington, Massachusetts

Overview

Takeda fosters a collaborative and stimulating work environment filled with opportunity and the chance to make a difference in people's lives. It is a workplace driven by integrity, one of Takeda’s long-held values that extends to both the patients we serve and our employees who develop and deliver medicines. Across our company, Takeda employees bring together diverse strengths that together create a stronger whole.

As one of the world’s leading biopharmaceutical companies, Takeda is committed to bringing Better Health and a Brighter future to people worldwide. We aspire to bring our leadership in translating science into life-changing medicines to the next level, in our core focus areas; oncology, gastroenterology, neuroscience, rare diseases, plasma-derived therapies, and vaccines. The Greater Boston Area is headquarters to many of our Global and US business units.

We are a passionate team doing important work that impacts patients’ lives. If you are driven to create better health and a brighter future, join us!

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Success

What makes a successful member of our team? Check out the traits we’re looking for and see if you have the right mix.

  • Collaborative
  • Strategic
  • Results Driven
  • Team Player
  • Versatile
  • Entrepreneurial

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Opportunity

  • Bold initiatives, continuous improvement, and creativity are at the heart of how we bring scientific breakthroughs from the lab to patients.

  • Since 1781, the values of Takeda-ism (Integrity, Fairness, Honesty, and Perseverance) have guided everything we do—from decision-making to interacting with patients.

  • Our people-first mission extends beyond patients to include their families, communities, and our own Takeda family.

  • Through trust and respect, you will have genuine support from leaders, managers, and colleagues to do your best work.

  • A strong, borderless team, we strive together towards our priorities and inspiring mission.

  • Recognized for our culture and way of working, we’re one of only 13 companies to receive Top Global Employer® status for 2020.

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Team Lead - CMC Systems Oversight

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Job ID R0015571 Date posted 01/08/2020 Location Lexington, Massachusetts; Boston, Massachusetts

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Job Description

Job Description – Associate Director, Systems Oversight

  • Demonstrates a high level of leadership and understanding of GRA-CMC roles, capabilities, and applicable CMC and GXP requirements relevant to the development and maintenance of systems and processes related to
    • Change management
    • Regulatory submissions
    • Post-marketing commitments
    • Clinical and commercial supply
  • Represents GRA-CMC on cross-functional teams developing and maintaining Quality, Supply and regulatory systems
  • Manages, develops and mentors staff members responsible for GRA-CMC change management procedures
  • Proactively recognizes and contributes to enhancing business processes
  • Responsible for adapting, developing or maintaining GRA-CMC procedures in accordance with Global, GRA, and PharmSci and GMS/GQ policies and standards
  • Responsible for developing and communicating meaningful metrics for post-approval submissions to facilitate resourcing decisions and planning
  • Responsible for supporting post-approval submissions and projects as an individual contributor where needed
  • Exercises good judgement in elevating and communicating actual or potential issues to line management
  • Ensures that stakeholders are kept aware of developments around systems and processes that have the potential to impact GRA-CMC resources and priorities

Education, Behavioral Competencies and Skills

  • Demonstrates Takeda’s leadership behaviors
  • Understanding of change control, regulatory submission requirements
  • Flexible, pragmatic, good communicator
  • Demonstrates ability to think strategically on systems issues, anticipate potential roadblocks and to collaborate with stakeholders to solve problems
  • Experience leading a team preferred

Locations

Lexington, MA

Boston, MA

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time

Job ID R0015571

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